Depomed dumping hot flash drug Sefelsa after FDA rejection
This article was originally published in Scrip
Executive Summary
Depomed President and CEO Jim Schoeneck said his company had pretty much accepted the likelihood the US FDA would reject Sefelsa (gabapentin 600mg) as a treatment for moderate-to-severe menopausal-related hot flashes and night sweats, a condition known as vasomotor symptoms (VMS), given the snub the firm got in March from the agency’s Advisory Committee for Reproductive Health Drugs (ACRHD).